01 1Fuxin Long Rui Pharmaceutical
02 1Lupin Ltd
03 1Viatris
01 2LEDIPASVIR
02 1LEDIPASVIR: PVP (1:1)
01 1China
02 1India
03 1U.S.A
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33491
Submission : 2019-07-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34446
Submission : 2019-12-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33430
Submission : 2018-12-28
Status : Active
Type : II
A Harvoni manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Harvoni, including repackagers and relabelers. The FDA regulates Harvoni manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Harvoni API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Harvoni manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Harvoni supplier is an individual or a company that provides Harvoni active pharmaceutical ingredient (API) or Harvoni finished formulations upon request. The Harvoni suppliers may include Harvoni API manufacturers, exporters, distributors and traders.
click here to find a list of Harvoni suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Harvoni DMF (Drug Master File) is a document detailing the whole manufacturing process of Harvoni active pharmaceutical ingredient (API) in detail. Different forms of Harvoni DMFs exist exist since differing nations have different regulations, such as Harvoni USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Harvoni DMF submitted to regulatory agencies in the US is known as a USDMF. Harvoni USDMF includes data on Harvoni's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Harvoni USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Harvoni suppliers with USDMF on PharmaCompass.
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